Events

Rappel de Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Coloplast Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01542-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-12-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01542-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    On november 28, 2017, the therapeutic goods administration (tga) notified coloplast of tga’s decision to remove transvaginal mesh products used to treat pelvic organ prolapse (pop), and single incision mini-slings from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.Following this direction from tga, coloplast is recalling all restorelle directfix anterior, restorelle directfix posterior, and altis single incision sling products from the australian market.No other coloplast devices are affected by this recall.
  • Action
    Coloplast is advising hospitals to quarantine any affected product for return to Coloplast. Instructions for product return are provided on the Customer Letter issued to affected customers.

Device

Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling
  • Modèle / numéro de série
    Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision SlingRestorelle DirectFix AnteriorModel/Catalogue Number: 501450SKU Number: 5014501022ARTG 190172Restorelle DirectFix PosteriorModel/Catalogue Number: 501460SKU Number: 5014601022ARTG 190172Altis Single Incision Sling SystemModel/Catalogue Number: 519650SKU Number: 5195601022ARTG 190173
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd